Purpose Prostate-specific membrane antigen (PSMA) is increasingly considered as a molecular target to achieve precision surgery for prostate cancer. A Delphi consensus was conducted to explore... Show morePurpose Prostate-specific membrane antigen (PSMA) is increasingly considered as a molecular target to achieve precision surgery for prostate cancer. A Delphi consensus was conducted to explore expert views in this emerging field and to identify knowledge and evidence gaps as well as unmet research needs that may help change practice and improve oncological outcomes for patients.Methods One hundred and five statements (scored by a 9-point Likert scale) were distributed through SurveyMonkey (R). Following evaluation, a consecutive second round was performed to evaluate consensus (16 statements; 89% response rate). Consensus was defined using the disagreement index, assessed by the research and development project/University of California, Los Angeles appropriateness method.Results Eighty-six panel participants (72.1% clinician, 8.1% industry, 15.1% scientists, and 4.7% other) participated, most with a urological background (57.0%), followed by nuclear medicine (22.1%). Consensus was obtained on the following: (1) The diagnostic PSMA-ligand PET/CT should ideally be taken < 1 month before surgery, 1-3 months is acceptable; (2) a 16-20-h interval between injection of the tracer and surgery seems to be preferred; (3) PSMA targeting is most valuable for identification of nodal metastases; (4) gamma, fluorescence, and hybrid imaging are the preferred guidance technologies; and (5) randomized controlled clinical trials are required to define oncological value. Regarding surgical margin assessment, the view on the value of PSMA-targeted surgery was neutral or inconclusive. A high rate of "cannot answer" responses indicates further study is necessary to address knowledge gaps (e.g., Cerenkov or beta-emissions).Conclusions This Delphi consensus provides guidance for clinicians and researchers that implement or develop PSMA-targeted surgery technologies. Ultimately, however, the consensus should be backed by randomized clinical trial data before it may be implemented within the guidelines. Show less
Long-term oncologic data on patients undergoing robot-assisted radical cystectomy (RARC) for non-metastatic bladder cancer (BCa) are limited. The purpose of this study is to describe long-term... Show moreLong-term oncologic data on patients undergoing robot-assisted radical cystectomy (RARC) for non-metastatic bladder cancer (BCa) are limited. The purpose of this study is to describe long-term oncologic outcomes of patients receiving robotic radical cystectomy at a high-volume European Institution. We analyzed data of 107 patients treated with RARC between 2003 and 2012 at a high-volume robotic center. Clinical, pathologic, and survival data at the latest follow-up were collected. Clinical recurrence (CR)-free survival, cancer-specific mortality (CSM)-free survival, and overall survival (OS) were plotted using Kaplan-Meier survival curves. Cox proportional hazard models investigated predictors of CR and CSM. Competing-risk regressions were utilized to depict cumulative incidences of death from BCa and death from other causes after RARC at long term. Pathologic nonorgan-confined BCa was found in 40% of patients, and 7 (7%) patients had positive soft tissue surgical margins. Median (interquartile range [IQR]) number of nodes removed was 11 (6, 14), and 26% of patients had pN + disease. Median (IQR) follow-up for survivors was 123 (117, 149) months. The 12-year CR-free, CSM-free and overall survival were 55% (95% confidence interval [CI] 44%, 65%), 62% (95% CI 50%, 72%), and 34% (95% CI 24%, 44%), respectively. Nodal involvement on final pathology was associated with poor prognosis on multivariable competing risk analysis. The cumulative incidence of non-cancer death exceeded that of death from BCa after approximately ten years after RARC. We provided relevant data on oncologic outcomes of RARC at a high-volume robotic center, with acceptable rates of clinical recurrence and cancer-specific survival at long-term. In patients treated with RARC, the cumulative incidence of death from causes other than BCa is non-negligible, and should be taken into consideration for post-operative follow-up. Show less
Background: Extended pelvic nodal dissection (ePLND) represents the gold standard for nodal staging in prostate cancer (PCa). Prostate-specific membrane antigen (PSMA) radioguided surgery (RGS)... Show moreBackground: Extended pelvic nodal dissection (ePLND) represents the gold standard for nodal staging in prostate cancer (PCa). Prostate-specific membrane antigen (PSMA) radioguided surgery (RGS) could identify lymph node invasion (LNI) during robotassisted radical prostatectomy (RARP).Objective: To report the planned interim analyses of a phase 2 prospective study (NCT04832958) aimed at describing PSMA-RGS during RARP.Design, setting, and participants: A phase 2 trial aimed at enrolling 100 patients with intermediate- or high-risk cN0cM0 PCa at conventional imaging with a risk of LNI of >5% was conducted. Overall, 18 patients were enrolled between June 2021 and March 2022. Among them, 12 patients underwent PSMA-RGS and represented the study cohort.Surgical procedure: All patients received Ga-68-PSMA positron emission tomography (PET)/magnetic resonance imaging; Tc-99m-PSMA-I&S was synthesised and administered intravenously the day before surgery, followed by single-photon emission computed tomography/computed tomography. A Drop-In gamma probe was used for in vivo measurements. All positive lesions (count rate >= 2 compared with background) were excised and ePLND was performed.Measurements: Side effects, perioperative outcomes, and performance characteristics of robot-assisted PSMA-RGS for LNI were measured.Results and limitations: Overall, four (33%), six (50%), and two (17%) patients had intermediate-risk, high-risk, and locally advanced PCa. Overall, two (17%) patients had pathologic nodal uptake at PSMA PET. The median operative time, blood loss, and length of stay were 230 min, 100 ml, and 5 d, respectively. No adverse events and intraoperative complications were recorded. One patient experienced a 30-d complication (ClavienDindo 2; 8.3%). Overall, three (25%) patients had LNI at ePLND. At per-region analyses on 96 nodal areas, sensitivity, specificity, positive predictive value, and negative predictive value of PSMA-RGS were 63%, 99%, 83%, and 96%, respectively. On a per-patient level, sensitivity, specificity, positive predictive value, and negative predictive values of PSMA-RGS were 67%, 100%, 100%, and 90%, respectively.Conclusions: Robot-assisted PSMA-RGS in primary staging is a safe and feasible procedure characterised by acceptable specificity but suboptimal sensitivity, missing micrometastatic nodal disease.Patient summary: Prostate-specific membrane antigen radioguided robot-assisted surgery is a safe and feasible procedure for the intraoperative identification of nodal metastases in cN0cM0 prostate cancer patients undergoing robot-assisted radical prostatectomy with extended pelvic lymph node dissection. However, this approach might still miss micrometastatic nodal dissemination. (c) 2022 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. Show less
Piazza, P.; Bravi, C.A.; Puliatti, S.; Cacciamani, G.E.; Knipper, S.; Amato, M.; ... ; Mottrie, A. 2022
Objectives: Radical cystectomy (RC) represents the gold standard treatment for high-risk bladder cancer. Despite evidence suggesting that surgical experience correlates with perioperative and... Show moreObjectives: Radical cystectomy (RC) represents the gold standard treatment for high-risk bladder cancer. Despite evidence suggesting that surgical experience correlates with perioperative and oncologic outcomes of robot-assisted RC (RARC), validated tools to assess its quality objectively are lacking. We aimed to evaluate the impact of RC-Pentafecta (absence of early major complications, absence of urinary diversion related sequelae at <= 12 months, absence of soft tissue surgical margins, >= 16 lymph nodes at final pathology and absence of clinical recurrence at <= 12 months) on oncological outcomes and the role of surgical experience on its achievement. Materials and methods: We retrospectively evaluated 366 patients undergoing RARC with intracorporeal urinary diversion in a single tertiary centre with a minimum of 1 year follow-up. Surgeries were performed using the DaVinci Xi system according to a previously described technique. Kaplan-Meier curves were used to investigate 5-years overall survival and cancer specific mortality-free survival (CSS) according to RC-Pentafecta achievement. Multivariable Cox's regressions were performed to evaluate the impact of RC-Pentafecta on overall mortality. Multivariable logistic regressions were performed to explore the effect of surgical experience on RC-pentafecta achievement. Locally weighted scatterplot smoother function was used to graphically explore this relationship. Results: Patients achieving RC-Pentafecta showed higher 5-year overall survival (71.8% vs. 59.6%, P < 0.001) and CSS (84% vs. 71%, P < 0.001) when compared with patients not achieving it. At multivariable Cox's regression, RC-Pentafecta achievement (HR 0.57, P = 0.03), positive surgical margins (HR 2.48, P = 0.002), pN+ (HR 2.23, P = 0.002), pT >= 3 (HR 1.71, P = 0.04) and current smoking status (HR 2.4, P = 0.006) were significant predictors of overall mortality. At multivariable logistic regression surgical experience (OR 1.2, P < 0.001), age (OR 0.93, P = 0.04), previous prostate surgery (OR 0.7, P = 0.02) and pT >= 3 (OR 0.8, P = 0.03) were independent predictors of RC-Pentafecta achievement. A linear relationship between surgical experience and RC-Pentafecta achievement, without reaching a plateau, was observed. Conclusions: RC-Pentafecta is a valuable tool to assess surgical quality of RARC and the experience of the center where the surgery is performed and may be used to identify "referral" centers for treatment of high-risk bladder cancer. (c) 2022 Elsevier Inc. All rights reserved. Show less
Fluorescence imaging is increasingly being implemented in surgery. One of the drawbacks of its application is the need to switch back-and-forth between fluorescence- and white-light-imaging... Show moreFluorescence imaging is increasingly being implemented in surgery. One of the drawbacks of its application is the need to switch back-and-forth between fluorescence- and white-light-imaging settings and not being able to dissect safely under fluorescence guidance. The aim of this study was to engineer 'click-on' fluorescence detectors that transform standard robotic instruments into molecular sensing devices that enable the surgeon to detect near-infrared (NIR) fluorescence in a white-light setting. This NIR-fluorescence detector setup was engineered to be press-fitted onto standard forceps instruments of the da Vinci robot. Following system characterization in a phantom setting (i.e., spectral properties, sensitivity and tissue signal attenuation), the performance with regard to different clinical indocyanine green (ICG) indications (e.g., angiography and lymphatic mapping) was determined via robotic surgery in pigs. To evaluate in-human applicability, the setup was also used for ICG-containing lymph node specimens from robotic prostate cancer surgery. The resulting Click-On device allowed for NIR ICG signal identification down to a concentration of 4.77 x 10(-6) mg/ml. The fully assembled system could be introduced through the trocar and grasping, and movement abilities of the instrument were preserved. During surgery, the system allowed for the identification of blood vessels and assessment of vascularization (i.e., bowel, bladder and kidney), as well as localization of pelvic lymph nodes. During human specimen evaluation, it was able to distinguish sentinel from non-sentinel lymph nodes. With this introduction of a NIR-fluorescence Click-On sensing detector, a next step is made towards using surgical instruments in the characterization of molecular tissue aspects. Show less
Developments within the field of image-guided surgery are ever expanding, driven by collective involvement of clinicians, researchers, and industry. While the general conception of the potential of... Show moreDevelopments within the field of image-guided surgery are ever expanding, driven by collective involvement of clinicians, researchers, and industry. While the general conception of the potential of image-guided surgery is to improve surgical outcome, the specific motives and goals that drive can differ between the different expert groups. To establish the current and future role of intra-operative image guidance within the field of image-guided surgery a Delphi consensus survey was conducted during the 2'd European Congress on Image-guided surgery. This multidisciplinary survey included questions on the conceptual potential and clinical value of image-guided surgery and was aimed at defining specific areas of research and development in the field in order to stimulate further advances towards precision surgery. Obtained results based on questionnaires filled in by 56 panel experts (clinicians: N=30, researchers: N=20 and industry: N=6) were discussed during a dedicated expert discussion session during the conference. The outcome of this Delphi consensus is indicative of the potential improvements offered by image-guided surgery and of the need for further research in this emerging-field, that can be enriched by the identification of reliable molecular targets. Show less
Despite good sensitivity and a good negative predictive value, the implementation of sentinel node biopsy (SNB) in robot-assisted radical prostatectomy with extended pelvic lymph node dissection ... Show moreDespite good sensitivity and a good negative predictive value, the implementation of sentinel node biopsy (SNB) in robot-assisted radical prostatectomy with extended pelvic lymph node dissection (ePLND) for prostate cancer is still controversial. For this reason, we aimed to define the added value of SNB (with different tracer modalities) to ePLND in the identification of nodal metastases. Complication rates and oncologic outcomes were also assessed. Methods: From January 2006 to December 2019, prospectively collected data were retrospectively analyzed from a single-institution database regarding prostate cancer patients treated with robot-assisted radical prostatectomy and ePLND with or without additional use of SNB, either with the hybrid tracer indocyanine green (ICG)-Tc-99m-nanocolloid or with free ICG. Multivariable logistic and Cox regression models tested the impact of adding SNB (either with the hybrid tracer or with free ICG) on lymph nodal invasion detection, complications, and oncologic outcomes. Results: Overall, 1,680 patients were included in the final analysis: 1,168 (69.5%) in the non-SNB group, 161 (9.6%) in the ICG-SNB group, and 351 (20.9%) in the hybrid-SNB group. The hybrid-SNB group (odds ratio, 1.61; 95%CI, 1.18-2.20; P = 0.002) was an independent predictor of nodal involvement, whereas the ICG-SNB group did not reach independent predictor status when compared with the non-SNB group (odds ratio, 1.35; 95%CI, 0.89-2.03; P = 0.1). SNB techniques were not associated with higher rates of complications. Lastly, use of hybrid SNB was associated with lower rates of biochemical recurrence (0.79; 95%CI, 0.63-0.98) and of clinical recurrence (hazard ratio, 0.76, P = 0.035) than were seen in the non-SNB group. Conclusion: The implementation of hybrid-SNB technique with ICG-Tc-99m-nanocolloid in prostate cancer improves detection of positive nodes and potentially lowers recurrence rates with subsequent optimization of patient management, without harming patient safety. Show less
Azargoshasb, S.; Houwing, K.H.M.; Roos, P.R.; Leeuwen, S.I. van; Boonekamp, M.; Mazzone, E.; ... ; Oosterom, M.N. van 2021
With translation of the Drop-In gamma-probe, radioguidance has advanced into laparoscopic robot-assisted surgery. Global-positioning-system-like navigation can further enhance the symbiosis between... Show moreWith translation of the Drop-In gamma-probe, radioguidance has advanced into laparoscopic robot-assisted surgery. Global-positioning-system-like navigation can further enhance the symbiosis between nuclear medicine and surgery. Therefore, we developed a fluorescence-video-based tracking method that integrates the Drop-In with navigated robotic surgery. Methods: Fluorescent markers, integrated into the Drop-In, were automatically detected using a daVinci Firefly laparoscope. Subsequently, a declipseSPECT-navigation platform calculated the Drop-In location within the surgical field. Using a phantom (n = 3), we pursued robotic navigation on SPECT/CT, whereas intraoperative feasibility was validated during porcine surgery (n = 4). Results: Video-based tracking allowed for navigation of the Drop-In toward all lesions detected on SPECT/CT (external iliac and common iliac artery regions). Augmented-reality visualization in the surgical console indicated the distance to these lesions in real time, confirmed by the Drop-In readout. Porcine surgery underlined the feasibility of the concept. Conclusion: Optical navigation of the Drop-In probe provides a next step toward connecting nuclear medicine with robotic surgery. Show less
BACKGROUND: To examine the predictive value of neutrophil-to-lymphocyte ratio in localized prostate cancer for surgical pathology and recurrence in patients treated by radical prostatectomyMETHODS:... Show moreBACKGROUND: To examine the predictive value of neutrophil-to-lymphocyte ratio in localized prostate cancer for surgical pathology and recurrence in patients treated by radical prostatectomyMETHODS: We evaluated 1258 patients treated by radical prostatectomy at San Raffaele Hospital between 2011 and 2017 and assessed the association between preoperative neutrophil-to-lymphocyte ratio and surgical pathology (advanced stage, grade group >= 4, nodal involvement, grade discordance between biopsy and surgical pathology) and biochemical recurrence.RESULTS: The preoperative neutrophil-to-lymphocyte ratio was not significantly associated with advanced stage (>= T3), International Society of Urological Pathology (ISUP) grade (>= 4) or discordance. At multivariable analysis, patients with higher neutrophil-to-lymphocyte ratio had lower risk of nodal involvement at final pathology (odds ratio [OR]: 0.77; 95% confidence interval [CI]: 0.64, 0.92; P=0.005). The preoperative level of neutrophil-to-lymphocyte ratio was associated with biochemical recurrence on univariate analysis (OR: 0.81, 95% CI: 0.68, 0.96; P=0.017). Such a relationship was not significant at multivariable analysis adjusting for tumor severity (OR: 0.93, 95% CI: 0.79, 1.09; P=0.4).CONCLUSIONS: Neutrophil-to-lymphocyte ratio does not have clinical utility for the prediction of adverse pathology and biochemical recurrence. Further research should focus on its value for predicting regional lymph node metastasis. Show less
Introduction The aim of this study was to report 36-month longitudinal changes using the North Star Ambulatory Assessment (NSAA) in ambulant patients affected by Duchenne muscular dystrophy... Show moreIntroduction The aim of this study was to report 36-month longitudinal changes using the North Star Ambulatory Assessment (NSAA) in ambulant patients affected by Duchenne muscular dystrophy amenable to skip exons 44, 45, 51 or 53. Materials and methods We included 101 patients, 34 had deletions amenable to skip exon 44, 25 exon 45, 19 exon 51, and 28 exon 53, not recruited in any ongoing clinical trials. Five patients were counted to skip exon 51 and 53 since they had a single deletion of exon 52. Results The difference between subgroups (skip 44, 45, 51 and 53) was significant at 12 (p = 0.043), 24 (p = 0.005) and 36 months (p <= 0.001). Discussion Mutations amenable to skip exons 53 and 51 had lower baseline values and more negative changes than the other subgroups while those amenable to skip exon 44 had higher scores both at baseline and at follow up. Conclusion Our results confirm different progression of disease in subgroups of patients with deletions amenable to skip different exons. This information is relevant as current long term clinical trials are using the NSAA in these subgroups of mutations. Show less
Background: The feasibility and efficacy of robot-assisted radical prostatectomy (RARP) in locally advanced prostate cancer (PCa) patients with iT3 lesion at magnetic resonance imaging (MRI) are... Show moreBackground: The feasibility and efficacy of robot-assisted radical prostatectomy (RARP) in locally advanced prostate cancer (PCa) patients with iT3 lesion at magnetic resonance imaging (MRI) are currently not explored.Objective: To describe our revised RARP technique (ie, superextended RARP [SE-RARP]) for PCa patients with posterior iT3a or iT3b at MRI.Design, setting, and participants: Data from 89 patients with posterior iT3a or T3b disease who underwent SE-RARP at a single high-volume centre between 2015 and 2018 were analysed. Surgical procedure: RARP was performed using a DaVinci Xi system. The surgical approach provided an inter- or extrafascial RARP where Denonvilliers' fascia and perirectal fat were dissected free and left on the posterior surface of the seminal vesicles.Measurements: Perioperative outcomes, and intra- and postoperative complications were assessed. Postoperative outcomes were assessed in patients with complete follow-up data (n = 78). Biochemical recurrence (BCR) was defined as two consecutive prostate-specific antigen values of >= 0.2 ng/ml. Urinary continence (UC) recovery was defined as the use of zero or one safety pad. Kaplan-Meier and multivariable Cox regression models were used.Results and limitations: The median operative time, blood loss, and length of stay were 204 min, 300 ml, and 5 d, respectively. The median bladder catheterisation time was 5 d. Overall, 28%, 28%, and 27% of patients had pathological grade group (GG) 4-5, pT3b, and positive surgical margins (PSMs), respectively. Three patients (3.4%) experienced intraoperative complications. Among patients with available follow-up data (n = 78), 14 (18%) experienced 30-d postoperative complications. The median follow-up was 19 mo. Overall, 11 patients received additional treatment. At 2 yr of follow-up, BCR-free and additional treatment-free survival were 55% and 66%, respectively. Pathological GG 4-5 (hazard ratio [HR] 3.2) and PSM (HR 5.8) were independent predictors of recurrence, as well as of additional treatment use (HR 5.6 for GG 4-5 and 5.2 for PSM). The 1-yr UC recovery was 84%.Conclusions: We presented our revised RARP technique applicable to patients with posterior iT3a or iT3b at preoperative MRI. This technique is associated with good morbidity and continence recovery rates, and might guarantee biochemical control of the disease and postpone the use of additional treatments in patients with low-grade and negative surgical margins.Patient summary: A revised robot-assisted radical prostatectomy technique applicable to prostate cancer patients with posterior iT3a or iT3b lesion at magnetic resonance imaging was described. This novel technique is feasible and safe in expert hands. (C) 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved. Show less
Dell'Oglio, P.; Palagonia, E.; Wisz, P.; Andras, I.; Groote, R. de; Poelaert, F.; ... ; YAU Working Grp Robot-Assisted Sur 2021
Objective To describe step-by-step surgical techniques and report outcomes of the largest single-centre series of patients with distal ureteric disease exclusively treated with robot-assisted... Show moreObjective To describe step-by-step surgical techniques and report outcomes of the largest single-centre series of patients with distal ureteric disease exclusively treated with robot-assisted ureteric reimplantation with Boari flap (RABFUR) and psoas hitch (RAPHUR), with a minimum follow-up of 1 year and complete postoperative data.Patients and Methods A total of 37 patients with distal ureteric disease were treated between 2010 and 2018. Of these, 81% and 19% underwent RAPHUR and RABFUR, respectively. Intra-, peri- and postoperative outcomes were assessed. The 90-day postoperative complications were reported according to the standardised methodology proposed by the European Association of Urology Ad Hoc Panel. Functional outcomes (creatinine, estimated glomerular filtration rate [eGFR]) and postoperative symptoms (visual analogue pain scale) were assessed.Results The median operating time and blood loss were 180 min and 100 mL, respectively. There were no conversions to open surgery and no intraoperative transfusions. The median length of stay, bladder catheter indwelling time and stent removal were 4, 7 and 30 days, respectively. The median follow-up was 24 months. Overall, 10 patients (27%) had postoperative complications and of these, eight (22%) and two (5.4%) were Clavien-Dindo Grade I-II and III, respectively. At the last follow-up, the median postoperative creatinine level and eGFR were 0.9 mg/dL and 73.5 mL/min/1.73 m(2), respectively. At the last follow-up, five (13.5%) and three (8%) patients had Grade 1 hydronephrosis and mild urinary symptoms, respectively. The study limitations include its retrospective nature.Conclusion In the present study, we present our RABFUR and RAPHUR techniques. We confirm the feasibility and safety profile of both approaches in patients with distal ureteric disease relying on the largest single-centre series with >= 1 year of follow-up. Show less
Dell'Oglio, P.; Mazzone, E.; Grivas, N.; Wit, E.; Donswijk, M.; Briganti, A.; ... ; Poel, H. van der 2021
Despite good sensitivity and a good negative predictive value, the implementation of sentinel node biopsy (SNB) in robot-assisted radical prostatectomy with extended pelvic lymph node dissection ... Show moreDespite good sensitivity and a good negative predictive value, the implementation of sentinel node biopsy (SNB) in robot-assisted radical prostatectomy with extended pelvic lymph node dissection (ePLND) for prostate cancer is still controversial. For this reason, we aimed to define the added value of SNB (with different tracer modalities) to ePLND in the identification of nodal metastases. Complication rates and oncologic outcomes were also assessed. Methods: From January 2006 to December 2019, prospectively collected data were retrospectively analyzed from a single-institution database regarding prostate cancer patients treated with robot-assisted radical prostatectomy and ePLND with or without additional use of SNB, either with the hybrid tracer indocyanine green (ICG)–99mTc-nanocolloid or with free ICG. Multivariable logistic and Cox regression models tested the impact of adding SNB (either with the hybrid tracer or with free ICG) on lymph nodal invasion detection, complications, and oncologic outcomes. Results: Overall, 1,680 patients were included in the final analysis: 1,168 (69.5%) in the non-SNB group, 161 (9.6%) in the ICG-SNB group, and 351 (20.9%) in the hybrid-SNB group. The hybrid-SNB group (odds ratio, 1.61; 95%CI, 1.18–2.20; P = 0.002) was an independent predictor of nodal involvement, whereas the ICG-SNB group did not reach independent predictor status when compared with the non-SNB group (odds ratio, 1.35; 95%CI, 0.89–2.03; P = 0.1). SNB techniques were not associated with higher rates of complications. Lastly, use of hybrid SNB was associated with lower rates of biochemical recurrence (0.79; 95%CI, 0.63–0.98) and of clinical recurrence (hazard ratio, 0.76, P = 0.035) than were seen in the non-SNB group. Conclusion: The implementation of hybrid-SNB technique with ICG–99mTc-nanocolloid in prostate cancer improves detection of positive nodes and potentially lowers recurrence rates with subsequent optimization of patient management, without harming patient safety. Show less
Dell'Oglio, P.; Mazzone, E.; Lambert, E.; Vollemaere, J.; Goossens, M.; Larcher, A.; ... ; Mottrie, A. 2021
Background: Evidence on the learning curve for robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) is limited.Objective: To assess the effect of surgical... Show moreBackground: Evidence on the learning curve for robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) is limited.Objective: To assess the effect of surgical experience (SE) on perioperative and intermediate-term oncological outcomes in a large contemporary cohort of RARC patients after accounting for the impact of intersurgeon variability.Design, setting, and participants: The study cohort included 164 patients treated with RARC and ICUD by two surgeons between 2004 and 2017 at a single European referral centre.Outcome measurements and statistical analysis: For each patient, SE was defined as the total number of RARCs performed by each surgeon before the patient's operation. The relationship between SE and operative time (OT), lymph node yield (LNY), positive surgical margins (PSMs), Clavien-Dindo grade >= 2 30-d postoperative complication (CD >= 2), and oncological outcomes (18-mo recurrence rate) was evaluated in multivariable linear and logistic regression models, clustering at a single-surgeon level.Results and limitations: After adjusting for case mix, SE was associated with shorter OT (p = 0.003), lower probability of postoperative CD >= 2 rates (p = 0.01), and lower 18-mo recurrence rates (p = 0.002). Conversely, SE did not predict lower PSM rates (p = 0.3) and higher LNY (p = 0.4). The relationship between SE and OT was nonlinear, with a plateau observed after 50 cases. Conversely, the relationship between SE and CD >= 2 and 18-mo recurrence was linear without reaching a plateau after 88 procedures.Conclusions: SE affects perioperative and oncological outcomes after RARC with ICUD in a linear fashion, and its beneficial effect does not reach a plateau. Conversely, after 50 cases, no further improvement was observed for OT.Patient summary: Robot-assisted radical cystectomy with intracorporeal urinary diversion is a complex surgical procedure with a relatively long learning curve. (C) 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved. Show less
Objective To develop and seek consensus from procedure experts on the metrics that best characterise a reference robot-assisted radical prostatectomy (RARP) and determine if the metrics... Show moreObjective To develop and seek consensus from procedure experts on the metrics that best characterise a reference robot-assisted radical prostatectomy (RARP) and determine if the metrics distinguished between the objectively assessed RARP performance of experienced and novice urologists, as identifying objective performance metrics for surgical training in robotic surgery is imperative for patient safety.Materials and methods In Study 1, the metrics, i.e. 12 phases of the procedure, 81 steps, 245 errors and 110 critical errors for a reference RARP were developed and then presented to an international Delphi panel of 19 experienced urologists. In Study 2, 12 very experienced surgeons (VES) who had performed >500 RARPs and 12 novice urology surgeons performed a RARP, which was video recorded and assessed by two experienced urologists blinded as to subject and group. Percentage agreement between experienced urologists for the Delphi meeting and Mann-Whitney U- and Kruskal-Wallis tests were used for construct validation of the newly identified RARP metrics.Results At the Delphi panel, consensus was reached on the appropriateness of the metrics for a reference RARP. In Study 2, the results showed that the VES performed similar to 4% more procedure steps and made 72% fewer procedure errors than the novices (P = 0.027). Phases VIIa and VIIb (i.e. neurovascular bundle dissection) best discriminated between the VES and novices. Limitations: VES whose performance was in the bottom half of their group demonstrated considerable error variability and made five-times as many errors as the other half of the group (P = 0.006).Conclusions The international Delphi panel reached high-level consensus on the RARP metrics that reliably distinguished between the objectively scored procedure performance of VES and novices. Reliable and valid performance metrics of RARP are imperative for effective and quality assured surgical training. Show less
Background: Sentinel node (SN) biopsy in penile cancer (PeCa) is typically performed using Tc-99m-nanocolloid and blue dye. Recent reports suggested that the hybrid (radioactive and fluorescent)... Show moreBackground: Sentinel node (SN) biopsy in penile cancer (PeCa) is typically performed using Tc-99m-nanocolloid and blue dye. Recent reports suggested that the hybrid (radioactive and fluorescent) tracer indocyanine green (ICG)-99mTc-nanocolloid may improve intraoperative optical SN identification.Objective: The current study aimed to confirm the reliability of ICG-Tc-99m-nanocolloid and to assess whether blue dye is still of added value.Design, setting, and participants: A total of 400 >= T1G2N0 PeCa patients were staged with SN biopsy at a single European centre. SNs were preoperatively identified with lymphoscintigraphy and single-photon emission computed tomography. Intraoperatively, SNs were detected via gamma tracing, blue staining, and fluorescence imaging.Outcome measurements and statistical analysis: All patients (n = 400, 740 groins) received ICG-Tc-99m-nanocolloid. Intraoperative SN identification rates were retrospectively evaluated. In those patients who received ICG-Tc-99m-nanocolloid and blue dye (n = 266, 492 groins), SN visualisation rates were compared using the McNemar test.Results and limitations: In total, 740 groins were assessed. No tracer-related (allergic) reactions were reported. All preoperatively defined SNs (n = 1163) were localised intraoperatively. Of all excised SNs, 98% were detectable with gamma probe and 96% were visible with fluorescence imaging. In the analysis of the patients who received ICG-Tc-99m-nanocolloid and blue dye, fluorescence imaging yielded a 39% higher SN detection rate than blue dye (95% confidence interval 36-43%, p < 0.001). Of the SNs that were tumour positive, 100% were intraoperatively visualised by fluorescence imaging, whereas merely 84% of the positive nodes stained blue.Conclusions: This study confirms that ICG-Tc-99m-nanocolloid is a reliable SN tracer for PeCa that significantly improves optical SN detection over blue dye.Patient summary: Hybrid indocyanine green (ICG)-Tc-99m-nanocolloid is a safe and reliable sentinel node (SN) tracer, as established in this large series of 400 penile cancer patients (740 groins). It enables accurate pre- and intraoperative SN identification and significantly improves SN detection rate compared with blue dye, without staining the surgical field or the need for an additional injection. (c) 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved. Show less
Palagonia, E.; Mazzone, E.; Naeyer, G. de; D'Hondt, F.; Collins, J.; Wisz, P.; ... ; Dell'Oglio, P. 2020
Purpose To assess the available literature evidence that discusses the effect of surgical experience on patient outcomes in robotic setting. This information is used to help understand how we can... Show morePurpose To assess the available literature evidence that discusses the effect of surgical experience on patient outcomes in robotic setting. This information is used to help understand how we can develop a learning process that allows surgeons to maximally accommodate patient safety. Methods A literature search of the MEDLINE/PubMed and Scopus database was performed. Original and review articles published in the English language were included after an interactive peer-review process of the panel. Results Robotic surgical procedures require high level of experience to guarantee patient safety. This means that, for some procedures, the learning process might be longer than originally expected. In this context, structured training programs that assist surgeons to improve outcomes during their learning processes were extensively discussed. We identified few structured robotic curricula and demonstrated that for some procedures, curriculum trained surgeons can achieve outcomes rates during their initial learning phases that are at least comparable to those of experienced surgeons from high-volume centres. Finally, the importance of non-technical skills on patient safety and of their inclusion in robotic training programs was also assessed. Conclusion To guarantee safe robotic surgery and to optimize patient outcomes during the learning process, standardized and validated training programs are instrumental. To date, only few structured validated curricula exist for standardized training and further efforts are needed in this direction. Show less
Introduction The available studies comparing robot-assisted radical cystectomy (RARC) with intracorporeal (ICUD) vs. extracorporeal (ECUD) urinary diversion have not relied on a standardized... Show moreIntroduction The available studies comparing robot-assisted radical cystectomy (RARC) with intracorporeal (ICUD) vs. extracorporeal (ECUD) urinary diversion have not relied on a standardized methodology to report complications and did not assess the effect of different approaches on postoperative outcomes. Materials Two hundred and sixty seven patients treated with RARC at a single center were assessed. A retrospective analysis of data prospectively collected according to a standardized methodology was performed. Multivariable logistic regression models (MVA) assessed the impact of ICUD vs. ECUD on intraoperative complications, prolonged length of stay (LOS), 30-day Clavien Dindo (CD) >= 2 complications and readmission rate. Interaction terms tested the impact of the approach on different patient subgroups. Lowess graphically depicted the probability of CD >= 2 after ICUD or ECUD according to patient baseline characteristics. Results Overall, 162 ICUD vs 105 ECUD (61 vs. 39%) were performed. Intraoperative complications were recorded in 24 patients. The median LOS and readmission rate were 11 vs. 13 (p = 0.02) and 24 vs. 22% (p = 0.7) in ICUD vs. ECUD, respectively. Overall, 227 postoperative complications were recorded. The overall rate of CD >= 2 was 35 and 43% in patients with ICUD vs. ECUD, respectively (p = 0.2). At MVA, the approach type was not an independent predictor of any postoperative outcomes (all p >= 0.4). Age-adjusted Charlson Comorbidity Index (ACCI) was associated with an increased risk of CD >= 2 (OR: 1.2, p = 0.006). We identified a significant interaction term between ACCI and approach type (p = 0.04), where patients with ICUD had lower risk of CD >= 2 relative to those with ECUD with increasing ACCI. Conclusions Relying on a standardized methodology to report complications, we observed that highly comorbid patients who undergo ICUD have lower risk of postoperative complications relative to those patients who received ECUD. Show less
